NCT06674655

Brief Summary

The researchers will conduct a study that combines motor imagery with therapeutic exercise in women experiencing menstrual pain. Previous research suggests that motor imagery, when used alongside physical exercise, may help improve motor control and alleviate pain, potentially enhancing outcomes for individuals dealing with chronic pain conditions. Through this study, the investigators aim to explore the effectiveness of these interventions in targeting key variables such as pain perception, motor coordination, and overall quality of life, building on existing evidence of motor imagery's benefits in pain management.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

January 9, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

November 8, 2024

Status Verified

November 1, 2024

Enrollment Period

7 months

First QC Date

November 2, 2024

Last Update Submit

November 5, 2024

Conditions

Keywords

Motor ImageryTherapeutic ExerciseMenstrual Pain

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    The main variable is the intensity of menstrual pain, which will be evaluated before, during and after the intervention using a verbal numerical scale (0-10), where 0 is no pain and 10 is maximum pain.

    Menstrual pain intensity will be assessed pre-intervention (T0), mid-intervention (T1-day 1, T2-day 2) and Post-intervention (T3-day 3).

Secondary Outcomes (2)

  • Lumbopelvic Motor Control

    Lumbopelvic motor control will be assessed pre-intervention (T0), mid-intervention (T1-day 1, T2-day 2) and Post-intervention (T3-day 3).

  • Pain Sensitivity

    Pain sensitivity will be assessed pre-intervention (T0), mid-intervention (T1-day 1, T2-day 2) and Post-intervention (T3-day 3).

Study Arms (3)

Motor Imagery Plus Therapeutic Exercise

EXPERIMENTAL
Behavioral: Motor Imagery Plus Therapeutic Exercise

Therapeutic Exercise

ACTIVE COMPARATOR
Behavioral: Therapeutic Exercise

Minimal Intervention

SHAM COMPARATOR
Behavioral: Minimal intervention

Interventions

This group will perform three days of lumbo-pelvic motor control exercise intervention along with a motor imagery intervention program during active breaks between exercises.

Motor Imagery Plus Therapeutic Exercise

This group will perform a lumbo-pelvic motor control exercise program for three consecutive days.

Therapeutic Exercise

This group will carry out a therapeutic counseling and minimal education intervention during a one-day intervention.

Minimal Intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women who have experienced menstrual pain for more than 6 months.
  • Pain intensity rated higher than 3/10 on a pain scale.
  • Participants do not take pain-relief medication during the study period.
  • Ages between 18 and 35 years old

You may not qualify if:

  • Current use of hormonal contraceptives or other treatments that affect menstrual cycles.
  • Any chronic pain condition unrelated to menstrual pain (e.g., fibromyalgia, chronic low back pain).
  • Diagnosed gynecological conditions such as endometriosis or pelvic inflammatory disease.
  • Pregnancy or breastfeeding.
  • Current use of psychoactive medications that could affect pain perception.
  • Any significant psychiatric condition that could interfere with study participation.
  • History of recent pelvic surgery (within the last 6 months).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Valencia

Valencia, Valènica, 46010, Spain

Location

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Central Study Contacts

Ferran Cuenca Martínez, Doctor of Physical Therapy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Physical Therapy

Study Record Dates

First Submitted

November 2, 2024

First Posted

November 5, 2024

Study Start

January 9, 2025

Primary Completion

July 30, 2025

Study Completion

September 1, 2025

Last Updated

November 8, 2024

Record last verified: 2024-11

Locations